FDA — authorised 20 October 2016
- Application: NDA203415
- Marketing authorisation holder: ASTELLAS
- Indication: Efficacy
- Status: approved
🇺🇸 Xtandi in United States
FDA authorised Xtandi on 20 October 2016
Marketing authorisations
FDA — authorised 22 January 2025
- Application: NDA213674
- Marketing authorisation holder: ASTELLAS
- Indication: Labeling
- Status: approved
The FDA approved Xtandi, manufactured by ASTELLAS, on January 22, 2025, under the application number NDA213674. This approval was granted through the standard expedited pathway. The approved indication for Xtandi is listed in its labeling, but the specific indication is not specified in the provided information.
Xtandi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Xtandi approved in United States?
Yes. FDA authorised it on 20 October 2016; FDA authorised it on 22 January 2025.
Who is the marketing authorisation holder for Xtandi in United States?
ASTELLAS holds the US marketing authorisation.